4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets... trends in biosafety.
LBM encouraged countries to accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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This concept note describes the methods used to assess the prevalence of any HIVDR and HIVDR by PMTCT exposure among children less than 18 months of age using remnant dried blood spot specimens from early infant diagnosis over a 12-month period
Any individual that meets the suspected case definition of monkeypox should be offered testing in appropriately equipped laboratories by staff trained in the relevant technical and safety procedures. Confirmation of monkeypox virus infection is based on nucleic acid amplification testing (NAAT), usi...ng real-time or conventional polymerase chain reaction (PCR), for detection of unique sequences of viral DNA. PCR can be used alone, or in combination with sequencing. The recommended specimen type for laboratory confirmation of monkeypox is skin lesion material, including swabs of lesion surface and/or exudate, roofs from more than one lesion, or lesion crusts.
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Élément culturel important, les plantes ont été utilisées pendant des siècles par les populations pour se soigner. Cependant, peu d’ethnies connaissent leur pharmacopée de par le manque d’études ethnobotaniques. La présente étude, réa...lisée en pays San, entité territoriale traditionnelle (Nord-Ouest du Burkina Faso), répond à ce souci de documenter les plantes médicinales. À travers une série d’enquêtes ethnobotaniques, 75 tradithérapeutes Sananont été interviewés. Les informations recherchées ont porté sur la plante, son nom local, ses parties utilisées, les pratiques médicales et les vertus thérapeutiques afférentes. Les résultats ont montré que 94 espèces végétales sont utilisées pour combattre différentes pathologies. Les feuilles (31 %), les racines (25 %) et les écorces du tronc (23 %) sont les principales parties utilisées pour préparer les recettes. Seules ou en association, ces parties interviennent dans l’élaboration des recettes par des procédés utilisant principalement la décoction (58 %), la trituration (17 %) et la macération aqueuse (11 %). Soixante-cinq pour cent (65 %) des produits obtenus sont administrés par voie orale via la boisson et les applications externes représentent 35 %. Treize catégories d’utilisation ont été recensées. Cependant, les tradipraticiens de santé sont en désaccord sur les thérapies proposées pour traiter ces catégories. La diversité des thérapies recensées en pays San, est une richesse culturelle. Ces données de la pharmacopée san sont une base pour une étude approfondie des aptitudes sylvicoles des plantes victimes de déracinement et la création de pépinières communautaires, afin de disposer de réservoirs de plantes médicinales proches des villages.
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Version 1.1. The WHO protocol has been adapted to resource-limited settings and builds on existing methodologies from the European Centre for Disease Prevention and Control (ECDC), the Global PPS project from University of Antwerp, the US Centers for Disease Control and Prevention (CDC), and the Med...icines Utilisation Research in Africa (MURIA).
Point Prevalence Surveys collects information on prescribing practices of antibiotics and other information relevant to treatment and management of infectious diseases in hospitalized patients, and complements surveillance of antimicrobial consumption.
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Antimicrobial Resistance Surveillance and Research Network | This manual describes well accepted methods to carry out drug susceptibility testing on important gram positive and gram negative clinically relevant bacteria. Methods of specimen collecti...on, transport, culture, anti-microbial drug susceptibility testing (common, special phenotypic and
molecular techniques) as well as quality control and quality assurance have been described in a concise manner.
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2nd edition .
This Framework applies to the sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits. This Framework does not apply to seasonal influenza viruses or other non-influenza pathogens or biological substances that may be contained in clinical ...specimens shared under this Framework
This second edition of the Pandemic Influenza Preparedness (PIP) Framework reflects an amendment to Annex 2, Standard Material Transfer Agreement 2, Footnote 1, that was adopted by the Seventy-second World Health Assembly in May 2019.The amendment clarifies that, under certain circumstances, the indirect use of PIP Biological Materials will require the conclusion of an SMTA2. The amendment is in effect from the closure of the Seventy-second World Health Assembly (28 May 2019).
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This document updates recommendations for HIV testing by laboratories in the United States and offers approaches for reporting test results to persons ordering HIV tests and to public health authorities. The recommended algorithm is a sequence of tests used in combination to improve the accuracy of ...the laboratory diagnosis of HIV based on testing of serum or plasma specimens. The updated recommendations also include tests for HIV antigens and HIV nucleic acid because studies from populations at high risk for HIV demonstrate that antibody testing alone might miss a considerable percentage of HIV infections detectable by virologic tests
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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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Following review of the latest evidence, WHO recommends that TB-LAMP can be used as a replacement for microscopy for the diagnosis of pulmonary TB in adults with signs and symptoms of TB. It can also be considered as a follow-on test to microscopy in adults with signs and symptoms of pulmonary TB, e...specially when further testing of sputum smear-negative specimens is necessary.
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13 May 2021
To avoid a reversal of progress from the adverse impacts of the COVID-19 pandemic, new knowledge and lessons from successful programmatic innovations are urgently needed to improve TB prevention and care. Experience can provide evidence for innovative approaches and strategies to mainta...in and scale up high-quality TB services. WHO therefore called for case studies on programmatic innovations that address emerging challenges in TB prevention and care during the pandemic in order to collect and disseminate the findings to the TB community. Between November 2020 and February 2021, a total of 23 case studies relevant to the call were accepted from 19 countries in the six regions of WHO. The lessons learnt from these country activities to ensure the continuity of essential services like TB care in the face of the crippling crisis may also inform strategies for minimizing the impact of future emerging pathogens on health services.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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Version 1.1 July 2016
The purpose of this document is to describe standard operating procedures for viral load monitoring, including the schedule for viral load testing when used for routine monitoring of children, adolescents and adults on ART; interpretation of results; patient management; an...d specimen collection, preparation and transport. This template document to be adapted for use in various contexts and is one component of a viral load monitoring toolkit, to be used in conjunction with ICAP’s Viral Load Monitoring Flipchart and Enhanced Adherence Treatment Plan.
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In this document, recommendations are provided on designing and implementing
a cross-sectional serosurvey using school-based sampling to estimate age-specific
DENV seroprevalence to inform a country’s national dengue vaccination program.
The document includes recommendations for methods for ...planning and conducting
serosurveys, including survey design, specimen collection, laboratory testing, data
analysis, and the interpretation and reporting of results.
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The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat...ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
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The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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Prepared as an outcome of ICMR Expert Group on Immunophenotyping of Hematolymphoid Neoplasms | Coordinated by Division of Non Communicable Diseases | This document addresses on various issue related to good quality practices in laboratory work up of flow cytometric immunophenotyping and will be of u...se to pathologists, cytometrists, hematologists, technologists and scientists working in this field.
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A manual for health care providers.
This manual provides expert guidance on the laboratory techniques and procedures used in the diagnosis of Buruli ulcer, a disease caused by Mycobacterium ulcerans. Aimed at laboratory technicians and scientists working on this disease, the manual details the exac...t procedures to follow when performing a range of diagnostic tests. Recommended procedures, intended for use throughout the health system, are presented at levels appropriate for peripheral, district and central services and in accordance with the varying resources, skills and equipment typically found in countries where Buruli ulcer is endemic.
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